Clinical Trials Directory

Trials / Completed

CompletedNCT07502469

Study Comparing the Contribution of G-Eye Combined With CAD-Eye Versus High-definition Colonoscopy With CAD-Eye in the Detection of Colonic Lesions After a Positive Immunological Test in the Context of Organized Colorectal Cancer (BENEFIT)

Single-center, Retrospective Study Comparing the Contribution of G-Eye (Balloon-assisted Endoscopy) Combined With CAD-Eye (Artificial Intelligence Polyp Detection) Versus High-definition Colonoscopy With CAD-Eye in the Detection of Colonic Lesions After a Positive Immunological Test in the Context of Organized Colorectal Cancer Screening.

Status
Completed
Phase
Study type
Observational
Enrollment
341 (actual)
Sponsor
Elsan · Academic / Other
Sex
All
Age
50 Years – 74 Years
Healthy volunteers
Not accepted

Summary

The incidence of colorectal cancer (CRC) is high in France, with approximately 45,000 new cases per year. The fecal immunochemical test (FIT) is used for screening for this cancer. If the test is positive, a colonoscopy is recommended. In recent years, French and European societies of digestive endoscopy have defined quality criteria for colonoscopy to reduce the risk of interval colorectal cancer (ICRC), that is, CRC occurring within 5 years of a colonoscopy considered negative. The operator's adenoma detection rate (ADR) is one of these factors. Its threshold is set at 45% within the framework of the organized CRC screening program, i.e., after a positive FIT. Artificial intelligence is emerging as an effective way to increase operators' ADR. Balloon-assisted endoscopy (G-Eye) also increases the TDA (transient anaerobic digestion). No French data are available regarding G-Eye, and there is limited data concerning CAD-Eye (artificial intelligence). No data exist on the combination of these two devices. Therefore, there is no data on the combination of these devices during a colonoscopy performed after a positive TIF (transient anaerobic digestion) test. It should be noted that all published studies were conducted in expert centers. The value of this study lies in its ability to collect real-world data.

Conditions

Interventions

TypeNameDescription
PROCEDUREColonoscopyColonoscopy performed between November 1st 2021 and June 30th 2024

Timeline

Start date
2024-11-05
Primary completion
2025-03-01
Completion
2025-03-01
First posted
2026-03-31
Last updated
2026-03-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07502469. Inclusion in this directory is not an endorsement.